Howmedica Osteonics Corp.
Mahwah, NJ
This page shows every FDA and USDA recall linked to Howmedica Osteonics Corp.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
219
Total Recalls
2004
First Recall
2025
Most Recent
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) wi...
Dec 19, 2025
· Device
Open, Classified
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442;
2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog...
Sep 26, 2025
· Device
Open, Classified
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Oct 9, 2024
· Device
Open, Classified
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applic...
Oct 7, 2024
· Device
Open, Classified
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Numbe...
Aug 26, 2024
· Device
Open, Classified
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty.
Catalog...
Jul 16, 2024
· Device
Open, Classified
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty.
Catalog...
Jul 16, 2024
· Device
Open, Classified
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty.
Catalog...
Jul 16, 2024
· Device
Open, Classified
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Jun 18, 2024
· Device
Open, Classified
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Jun 18, 2024
· Device
Open, Classified
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation
C...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation
C...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation...
Apr 25, 2024
· Device
Open, Classified
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Mar 6, 2024
· Device
Open, Classified
X3 TRIATHLON CS INSERT NO 6 10 MM
Mar 6, 2024
· Device
Open, Classified
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Mar 6, 2024
· Device
Open, Classified
X3 TRIATHLON CS INSERT NO 3 10 MM
Mar 6, 2024
· Device
Open, Classified
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Mar 6, 2024
· Device
Open, Classified
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Mar 6, 2024
· Device
Open, Classified
X3 TRIATHLON CS INSERT NO 7 9 MM
Mar 6, 2024
· Device
Open, Classified
X3 TRIATHLON CS INSERT NO 6 11 MM
Mar 6, 2024
· Device
Open, Classified
HRIS ACET CUP CUT TIP 32X140
Part Number: 6210-5-200rker.
single-use, sterile surgical instruments used dur...
Feb 6, 2024
· Device
Open, Classified
HRIS ACET CUP CUT TIP 26X140
Part Number: 6210-5-100.
single-use, sterile surgical instruments used during...
Feb 6, 2024
· Device
Open, Classified
SCORPIO TS TIB INSERT -Intended for knee replacement
Part Number: 72-4-0321
Jan 31, 2024
· Device
Open, Classified
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement
Part Number: 73-2110
Jan 31, 2024
· Device
Open, Classified
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement
Product Number: 6637-0-831
Jan 31, 2024
· Device
Open, Classified
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement
Part Number: 73-2910
Jan 31, 2024
· Device
Open, Classified
DUR PCA MTK REV INS LFT
Intended for knee replacement
Product Number: 6728-2-611
Jan 31, 2024
· Device
Open, Classified
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3308
Jan 31, 2024
· Device
Open, Classified
DUR PCA MTK REV INS RT
Intended for knee replacement
Product Number: 6728-2-711
Jan 31, 2024
· Device
Open, Classified
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement
Part Number: 73-2710
Jan 31, 2024
· Device
Open, Classified
PS LIPPED TIBIAL INSERT ASSY DURACON
Intended for knee replacement
Product Number: 6742-1-411
Jan 31, 2024
· Device
Open, Classified
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT
Intended for knee replacement
Part Number: 620-00-32J
Jan 31, 2024
· Device
Open, Classified
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3508
Jan 31, 2024
· Device
Open, Classified
SCORPIO RECESSED PATELLA-Intended for knee repalcment
Part Number: 3044-0032
Jan 31, 2024
· Device
Open, Classified
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT
Intended for knee replacement
Product Number: 6637-0-928
Jan 31, 2024
· Device
Open, Classified
SCORPIO U-DOME PATELLA -Intended for knee replacement
Part Number: 73-3910
Jan 31, 2024
· Device
Open, Classified
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement
Part Number: 72-16-0910
Jan 31, 2024
· Device
Open, Classified
SCORPIO TS TIB INSERT-Intended for knee replacement
Part Number:72-4-7512
Jan 31, 2024
· Device
Open, Classified
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement
Part Number: 82-2-0908
Jan 31, 2024
· Device
Open, Classified
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement
Part Number: 73-0510
Jan 31, 2024
· Device
Open, Classified